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Fellowship in Regulatory Science

The Fellowship in Regulatory Science provides scientific training needed to modernize and improve the way medical products are developed, reviewed, and evaluated. Established in 2014, the Georgetown University Fellowship in Regulatory Science provides fellows with one to two years of specialized training with access to expert faculty and scientists from Georgetown University, industry partners, and the U.S. Food and Drug Administration (FDA).

Fellows conduct research, learn, teach, and mentor graduate and undergraduate students. Each fellow is awarded up to two years of salary support and research stipends, beginning with a one-year term, with possibilities for renewal after successful completion of the first year. This postgraduate fellowship will help develop researchers and scholars to reach their fullest potential in advancing innovative research to benefit public health.

Regulatory science is an applied scientific discipline that generates and makes use of evidence-based knowledge to inform decision-making about the safety and benefits of medical products, and comprises an emerging, specialized, and interdisciplinary field of biomedical research and education. Early in its evolution, the field holds great promise for scholarship, innovation, and application to enhance the safety and effectiveness of medical products and improve public health.

Fellow Qualifications

Ideal candidates will demonstrate a strong interest in regulatory science through their professional and educational backgrounds. Candidates should be enthusiastic, self-motivated individuals who are able to articulate a strong interest in regulatory science, and have a deep desire to develop their careers at the intersection of academia, industry and government. Specifically, candidates should possess the following qualifications:

Michael J. Fox Foundation Sponsorship

The Michael J. Fox Foundation (MJFF) announced its support of the Fellowship in Regulatory Science at Georgetown University. This fellowship will provide a postgraduate training opportunity and will advance innovative research benefiting Parkinson’s disease.

2017 Fellow in Regulatory Science for Parkinson Disease Research

Monica Javidnia, PhD, is a Fellow in Regulatory Science for Parkinson Disease Research, beginning December 2017. She earned her PhD in Pharmacology in the fall of 2017 from Georgetown University. She completed her dissertation in the Department of Neurology Translational Neurotherapeutics Program with Dr. Charbel Moussa whose lab, The Laboratory for Dementia and Parkinsonism, focuses on repurposing FDA-approved cancer drugs (tyrosine kinase inhibitors) for neurodegenerative diseases. Her research focused on a renal cell carcinoma drug in two mouse models of neurodegeneration. She found the drug was well tolerated, modulated inflammation, and reduces p-tau levels, the protein in Alzheimer’s disease ‘tangles.’ This work was published in the Journal of Alzheimer’s Disease and presented at several conferences including the Alzheimer’s Association International Conference in 2016 and 2017 and was selected for a nanosymposium presentation at the Society for Neuroscience Conference in 2017. In parallel, she worked on a Phase II clinical trial for the chronic myelogenous leukemia drug nilotinib in mild-to-moderate Alzheimer’s disease. These experiences helped her gain insights into what it takes to bring a drug from the lab bench to the clinic.

Dr. Javidnia began her fellowship in December 2017 in a collaborative effort with the Georgetown University Program in Regulatory Science & Medicine (PRSM), the University of Rochester Experimental Therapeutics of Neurological Disorders Fellowship program, Voyager Therapeutics, and the U.S. Food & Drug Administration (FDA). This work aims to provide a natural history of Parkinson’s disease (PD) progression to aid researcher and clinician efforts in PD diagnosis and treatment. She will also assist in expanding the CERSI Scholars program to the University of Rochester.

PhRMA Sponsorship

The Pharmaceutical Research and Manufactures of America (PhRMA) provided initial sponsorship for the Fellowship in Regulatory Science. Over time, PhRMA has and continues to support the training of three fellows at Georgetown University. Read more about each of the PhRMA-supported fellows below.

2016 Fellow in Regulatory Science

Daphne Guinn, PhD, is a PRSM-PhRMA fellow in regulatory science. She received her PhD in Biomedical Sciences in May 2016 from The Ohio State University. While at Ohio State, she worked in a translational laboratory developing novel therapeutics for chronic lymphocytic leukemia (CLL). One of her projects was focused on elucidating the microRNA profile associated with ibrutinib therapy in primary patient samples. Ibrutinib is an irreversible inhibitor of Bruton’s tyrosine kinase (BTK), which is an integral kinase in the B cell receptor signaling pathway and is essential to the survival of CLL tumor cells. That work lead to the identification of oncogenic miR-155, which Dr. Guinn and her colleagues found to be associated with poor prognosis markers in CLL and could be down-modulated in patients treated with ibrutinib. This work was published in the journal Leukemia and presented at the 2014 American Society of Hematology meeting. She also worked on another project that focused on studying the impact that acquired ibrutinib resistant mutations have on CLL biology and disease progression. She developed ibrutinib-resistant cell lines as a model to study resistance. This work earned her authorship on two publications in Blood.

During her PhD, Dr. Guinn was exposed to pre-clinical and clinical development of therapeutics. Those experiences led her to pursue a career in regulatory science to further study clinical drug development with a particular interest in adaptive clinical trial designs and modernization of the therapeutic review process.

She began her fellowship in August 2016 and will use this training opportunity to pursue her interest in adaptive clinical trial designs by working with academic, industry, and FDA mentors to design and simulate a late-phase basket trial informed by real-world data. This type of novel clinical trial design would serve to improve the development process for niche or orphan indications. She will also assist in building the CERSI Scholars program and advocate for the importance of regulatory science through education and research.

2015 Fellow in Pediatric Regulatory Science

Evgenia (Jenny) Gourgari, MD, is an Assistant Professor of Pediatric Endocrinology at MedStar Georgetown University Hospital and was a PRSM-PhRMA fellow in pediatric regulatory science from 2015-2016. She received her Medical Degree from Aristotle University (Greece) and became Board Certified in Pediatrics in 2010 after completing her residency at Miami Children’s Hospital. She completed her Pediatric Endocrine Fellowship at NIH where she was not only trained to manage common endocrine conditions in children, such as diabetes, short stature, puberty disorders and PCOS, but also she was exposed to the rigors of scientific research. During her fellowship Dr. Gourgari was the lead investigator and responsible for all aspects of conduct of the clinical protocol “Adrenal hyperplasia among young women with Polycystic Ovary Syndrome (PCOS)”. She received three awards from the Endocrine Society for her work and has published several original research manuscripts.

Dr. Gourgari was fascinated by the presence of multiple lipoprotein abnormalities in this young group of PCOS patients and that sparked her interest in the role of lipoproteins in stratifying the cardiovascular risk in children with other risk factors for cardiovascular disease such as diabetes. She joined Georgetown University as a new faculty member in 2013, where she encountered new challenges in clinical management as nearly a third of her patients have type 1 diabetes and are therefore at increased risk for Cardiovascular Disease (CVD). Dr. Gourgari was successful in receiving two pilot awards in 2014 to further investigate the lipoprotein abnormalities in children with diabetes and she is now the Principal Investigator of the study, ”Identifying children with diabetes at high risk for cardiovascular disease.”

In June 2015, she accepted the regulatory science fellowship. This training opportunity gave Dr. Gourgari the tools to navigate further into the pathophysiology of lipoprotein anomalies using a bio-informatics approach. Furthermore, Dr. Gourgari was trained on the regulatory aspects of conducting a clinical trial in pediatric populations using experimental drugs.

2014 Fellow in Regulatory Science

Shahla Riazi, MD, Ph.D., was the inagural PRSM-PhRMA Fellow in Regulatory Science at Georgetown University. Her appointment was through the Georgetown University Program for Regulatory Science & Medicine (PRSM) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Fellowship in Regulatory Science. Dr. Riazi engaged with Georgetown's Innovation Center for Biomedical Informatics on regulatory science research. She completed her Master of Science in Clinical and Translational Research at Georgetown University at the same time. In addition to regular meetings with her mentors from Georgetown and industry partner Biogen, Dr. Riazi had the opportunity to engage with FDA, present her work at several conferences, and spend time at Biogen’s headquarters, experiencing the inner workings of a biopharmaceutical company.

Since completing her fellowship in 2015, Dr. Riazi joined the staff at the U.S. Food and Drug Administration.

About PRSM and Partners

PRSM seeks to advance regulatory science and medicine through research and education, drawing on the expertise of a diverse group of scholars and knowledgeable faculty. PRSM includes an array of innovative research and education opportunities, engaging faculty, students, and researchers at the university in the rapidly developing field of regulatory science. With proximity to regulators and scientists in government, academia, and industry, Georgetown University offers a unique milieu for regulatory science training and research.

PhRMA represents the country’s leading innovative biopharmaceutical research companies that are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $550 billion in the search for new treatments and cures, including an estimated $51.1 billion in 2013 alone.

The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. As the world’s largest nonprofit funder of Parkinson’s research, The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers.

PRSM and its partners value the human, educational, and research resources that encompass evidence-based regulatory science and are committed to supporting and sustaining education, training, mentoring, and scholarship in regulatory science.